Clinical Trail Administrator

Вакансия № 18555674 от компании ООО Ново Нордиск на Электронной Службе Занятости Населения Москвы.

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☑ Основной блок:

Опыт работы: 1–3 года.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 18555674 добавлено в базу данных: Суббота, 1 марта 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Статистика предложения работы № 18555674:

Прочитано соискателями - 160 раз(а);
Отправлено откликов - 0 раз(а);

☑ Репутация компании "ООО Ново Нордиск":

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☑ Подробности о вакантном месте:

Are you ready to make the next step in your professional development in a global expanding company? Join Novo Nordisk Russia and get a life-changing career!

We are looking for a clinical trial administrator who will provide support to Project Managers and all CRAs within the Clinical Development Center CDC in the Russian Affiliate. You will directly report to the SDS Project Manager. The Job location is in Moscow office in the Krylatskiye Hills business center.

About the department

Clinical research is an area within Clinical & Medical & Regulatory function, responsible for delivering fast and high quality clinical data to support research & development portfolio of Novo Nordisk products in Russia.

You will join a team of more than 40 highly skilled CRAs and Project Managers; you will be located at Moscow office facility.

The position

In the CTA role you will provide clinical trial administration support to CDC Project Managers and all CRAs within the CDC country and adjacent affiliates involved in assigned clinical trials.

You will support CRAs in all relevant aspects of trial preparation, execution and finalisation to facilitate the process towards timely clinical project deliverables of required quality. You will be an essential member of the trial team, and has a significant role in conducting trial related tasks in a proactive and independent manner.

You will ensure oversight of all trial documentation for assigned clinical trial, covering all involved adjacent affiliates within the CDC: CTA documentation to support affiliates in HA and EC submissions - Ensure overview of local requirements;

Provide support in preparation and submission of clinical trial application (CTA) package and any changes to Ethics committee and/or Health Authority from creation of specific document till preparation of submission file;

Assist in/perform QC of trial documents such as translations;

Set-up/maintenance of Sponsor Trial Master File (STMF) tasks (Country and Site specific documents);

Assist in preparation of initial Investigator Trial Master Files (ITMFs);

Support in organisation of local meetings, external meeting planning, preparation, and follow-up (e.g. Investigator meetings, evaluation forms and reimbursements of investigators) according to applicable guidelines; arrange and attend relevant department meetings and teleconferences; including preparation and distribution of minutes

Other administrative tasks as relevant.

Qualifications

Bachelor’s Degree, life science or nursing qualification or equivalent (desirable)
Basic GCP qualification
Technical Skills

Knowledge of clinical trial methodology
Knowledge of the clinical trials environment – ICH GCP, regulatory issues, SOPs
Knowledge of drug development process
Good working knowledge of electronic clinical trials systems – IMPACT, EDC, IWRS, electronic TMF
English verbal and written skills on good level
Computer literacy and IT skills

Min. 1 year of experience in healthcare industry/ or customer service based employment
Preferably knowledge of medical/pharmaceutical terminology

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.